Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446329

Enrollment

Registered

2007-03-12

Start date

2006-07-31

Completion date

Unknown

Last updated

2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Brief summary

The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day. The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.

Interventions

DRUGcinacalcet

Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age older than 18 yrs * On hemodialysis for at least 3 months (thrice weekly) * iPTH \>300pg/ml or histological evidence of secondary hyperparathyroidism * Calcium \> 8.1 mg/dl

Exclusion criteria

* Unstable clinical condition

Design outcomes

Primary

Measure	Time frame
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients	one year period

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026